Penile prosthetic with an insertion sleeve attachable to an inflatable bladder

ABSTRACT

A penile prosthetic includes a penile implant sized for insertion into a dilated corpora cavernosum of a penis and an insertion sleeve. The penile implant includes a proximal tip that is insertable into a crus penis and an inflatable bladder connected to the proximal tip. The inflatable bladder has a first column strength and includes a distal tip that is insertable into a glans penis. The insertion sleeve is attachable to an outside surface of the inflatable bladder. The insertion sleeve is soluble in saline or water.

SUMMARY

One aspect provides a penile implant having a proximal tip that isinsertable into a crus penis, an inflatable bladder having a distal tipthat is insertable into a glans penis, with the inflatable bladdersealed to the proximal tip, and an insertion sleeve attachable over theinflatable bladder. The insertion sleeve dissolves after implantation ofthe penile implant into a patient.

The insertion sleeve allows the surgeon to push the penile implant intothe penis without the use of secondary tools, such as a Furlow device ora Keith needle.

The insertion sleeve provides the penile implant with sufficientrigidity to allow the penile implant to be inserted into a corporotomyand subsequently pushed in a distal direction into the glans penis. Inthe presence of liquid, for example during irrigation or body fluidsafter implantation, the insertion sleeve dissolves and is absorbed bythe body.

One aspect provides a method of implanting a penile prostheticincluding:

forming an incision in skin of a penis;

exposing a corpora cavernosum of the penis;

inserting an insertion sleeve into the corpora cavernosum of the penis,where the insertion sleeve is dissolvable in water;

inserting a penile implant into the insertion sleeve; and

closing the incision in the skin of the penis.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of a penile prostheticincluding a pump connected to two penile implants, a reservoir, andinsertion sleeves attachable to the penile implants.

FIG. 2 is a perspective view of an insertion sleeve.

FIG. 3 is an end view of an insertion sleeve.

FIG. 4 is a side view of the insertion sleeve illustrated in FIGS. 2 and3 attached to an inflatable bladder of the penile implant.

FIG. 5 is a schematic view of one of the penile implants illustrated inFIG. 1 demonstrating the insertion sleeve providing the penile implantwith increased column strength.

FIGS. 6-8 are schematic views of an implantation procedure for placementof the penile implants illustrated in FIG. 1 into a penis.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings. The drawings form a part of this specificationand illustrate exemplary embodiments for practicing the invention.Directional terminology, such as “top,” “bottom,” “front,” “back,”“leading,” “trailing,” etc., is used with reference to the orientationof the Figure(s) being described. Because components of embodiments canbe positioned in a number of orientations, the directional terminologyis used for purposes of illustration and is in no way limiting. It is tobe understood that other embodiments may be utilized and structural orlogical changes may be made without departing from the scope of theinvention. The detailed description describes examples for practicingthe invention and is not to be read to limit the scope of the invention.The scope of the invention is defined by the attached claims.

Embodiments, and features of the various exemplary embodiments describedin this application, may be combined with each other (“mixed andmatched”), unless specifically noted otherwise.

End means endmost. Relative to an observer, for example a surgeon, adistal end is the furthest endmost location of a distal portion of athing being described, whereas a proximal end is the nearest endmostlocation of a proximal portion of the thing being described. The portionnext to or adjacent to an end is an end portion.

An implanted penile prosthetic has proven useful in treating erectiledysfunction in men. One acceptable implanted penile prosthetic includestwo inflatable cylinders implanted in the penis, a pump implanted in thescrotum or other internal space of the body, and a liquid holdingreservoir implanted in the abdomen or other internal space of the body,with the pump connected to the cylinders and the reservoir.

In an implantation procedure, the penis of the patient is incised in acorporotomy to expose a pair of corpora cavernosa that are alignedaxially in a side-by-side orientation within the penis. A cuttingimplement, such as a curved Mayo scissors, is employed to penetrate thefascia of the penis and form an opening accessing each corporacavernosum. Subsequently, each corpora cavernosum is dilated (opened)with an appropriate dilation tool to form a recess that is sized toreceive one of the two cylinders of the penile prosthetic.

Thereafter, a tool (referred to by surgical practitioners as a “Furlow”introducer) is inserted into each dilated corpora cavernosum to measurea length of the penis distally and proximally to determine a desiredlength of the cylinders to be implanted. A cylinder of the appropriatelyselected length is secured to a suture, and the suture is secured to aneedle (sometimes called a “Keith” needle). The Keith needle is attachedto the Furlow introducer. The Keith needle could possibly fall out ofthe Furlow introducer, so the surgical staff handles the tool with care.The surgeon inserts the Furlow introducer into the dilated corporacavernosum. The surgeon steadies the Furlow introducer with one hand andpushes a plunger (or obturator) of the Furlow introducer with the otherhand. Pushing the plunger pushes the needle from of the introducer,through tissue of the penis, and out the glans penis. The exposedportion of the needle is handled by the surgeon, removed from thesuture, and discarded. The remaining suture is subsequently employed totow the cylinder into place within the dilated corpora cavernosum.

The above-described procedure has proven effective when implantingpenile prostheses. However, surgeons would appreciate having fewer partsto handle during the procedure. In addition, surgeons and those handlingthe Keith needle would possibly welcome an approach for implanting apenile prosthetic that reduces or eliminates their exposure to the Keithneedle.

This disclosure describes several embodiments that address the problemof the Keith needle falling out of a Furlow tool during the procedureand the surgeon handling a variety of components including a needle, asuture, and a Furlow tool by providing a solution where an insertionsleeve is attached to an outside surface of a penile implant to providean effective column strength allowing insertion of the implant into thepenis without external tools, needles, or sutures.

One embodiment provides a penile prosthetic having an insertion sleeveattachable to the outside surface of an inflatable penile implant. Theinflatable penile implant is sized for insertion into a dilated corporacavernosum of a penis and includes a proximal tip that is insertableinto the crus penis and a bladder connected to the proximal tip. Thebladder includes a distal tip that is insertable into the glans penis.The insertion sleeve provides the bladder with a column strength that issufficient for insertion of the bladder into the dilated corporacavernosum of the penis. The insertion sleeve dissolves and is absorbedby the body after implantation of the penile implant and closure of thecorporotomy.

A column strength that is sufficient for insertion of the penile implantinto the dilated corpora cavernosum of the penis is a column strengththat is stronger than a column strength of the bladder portion of apenile implant. For example, an inflatable penile implant is providedwith a soft and pliable inflatable bladder connected to a proximal tip.While the proximal tip is harder and stronger than the rest of thepenile implant (to support the implant against the bony structure of thecrus penis), the implant has a column strength associated with the leaststrong component, which is the bladder. The soft and pliable bladder hasa column strength in a range from about 4-12 ounces (about one-quarterto about three-quarters of a pound force). The bladder is designed to becompliant when deflated so that the penis is naturally flaccid when theimplant is not erect. A consequence of the pliability is that the columnstrength of the bladder is insufficient to allow the bladder to bepushed into the dilated corpora cavernosum during implantation. For thisreason, the bladder is typically towed into position by a Furlow needleattached to a length of suture. The Furlow needle pierces the glanspenis and the suture tows the bladder into the dilated corporacavernosum.

A column strength that is sufficient for insertion of the penile implantinto the dilated corpora cavernosum of the penis is a column strength ofabout 1 pound force or greater, with a realistic upper limit for thecolumn strength being about 20 pounds force. One useful column strengthfor the penile implant as provided by the insertion sleeve is in a rangefrom 1-10 pounds force. While the column strength can be larger than 10pounds force, a surgeon will generally back off from pushing with morethan 10 pounds force and inspect the cavity (corpora cavernosum in thedistal direction and the dilated crus in the proximal direction) todetermine why resistance is being met.

One embodiment provides a penile prosthetic having a penile implantsized for insertion into a dilated corpora cavernosum of a penis, and aninsertion sleeve attachable to an outside surface of the penile implant.The insertion sleeve is fabricated from a gelling agent that isconfigured to dissolve in water.

One embodiment provides a penile prosthetic having a penile implantsized for insertion into a dilated corpora cavernosum of a penis, and aninsertion sleeve attachable to an outside surface of the penile implant.The insertion sleeve dissolvable in an aqueous liquid having atemperature in a range from 70-100 degrees Fahrenheit.

One embodiment provides a penile prosthetic having a penile implantsized for insertion into a dilated corpora cavernosum of a penis, and aninsertion sleeve attachable to an outside surface of the penile implant.The insertion sleeve is formed from one or more of, or combinations of astarch, polysaccharides, derivatives of polysaccharides, sugar, simplesugars, fructose, derivatives of fructose, modified forms of starch, ormodified forms of starch and cellulose.

One embodiment provides a penile prosthetic having a penile implantsized for insertion into a dilated corpora cavernosum of a penis, and aninsertion sleeve attachable to an outside surface of the penile implant.The insertion sleeve is formed from one of a gelatin, a collagen, or acarrageenan.

One embodiment provides a penile prosthetic having a penile implantprovided as an inflatable bladder that is sized for insertion into adilated corpora cavernosum of a penis, and an insertion sleeveattachable to an outside surface of the penile implant. The inflatablebladder has a first column strength in a range from ¼-¾ pounds force,and the insertion sleeve provides the penile implant with an effectivecolumn strength in a range from 1-10 pounds force.

One embodiment provides a penile prosthetic having a penile implantsized for insertion into a dilated corpora cavernosum of a penis, and aninsertion sleeve attachable to an outside surface of the penile implant.The insertion sleeve has a durometer in a range from 40 Shore A to 70Shore A.

One embodiment provides a penile prosthetic having an insertion sleeveattachable to the outside surface of an inflatable penile implant. Theinflatable penile implant is sized for insertion into a dilated corporacavernosum of a penis and includes a proximal tip that is insertableinto the crus penis and a bladder connected to the proximal tip. Thebladder includes a distal tip that is insertable into the glans penis.The insertion sleeve provides the bladder with a column strength that issufficient for insertion of the bladder into the dilated corporacavernosum of the penis. The proximal tip has a durometer in a rangefrom 40 Shore A to 70 Shore A and the distal tip is softer than theproximal tip and has a durometer in a range from 0 Shore A to 39 ShoreA.

FIG. 1 is a perspective view of one embodiment of an implantable penileprosthetic 20. The penile prosthetic 20 includes a reservoir 22 sized tocontain a volume of liquid, a pump 24 connected to the reservoir 22 andoperable to move the liquid out from the reservoir 22 and back into thereservoir 22, and a pair of penile implants 26, where one each of thepenile implants 26 is body implantable in a corpora cavernosum of apenis. Each penile implant 26 includes a bladder 28 permanently attachedto a proximal tip 30. The bladder 28 is inflatable with the liquid fromthe reservoir 22 and includes a closed distal tip 32 that is insertableinto the glans penis, and the proximal tip 30 is insertable into thecrus penis and includes a tubing port 34 communicating between thebladder 28 and the pump 24. An insertion sleeve 40 is provided that issized to be attached over each of the bladders 28.

The reservoir 22 is attachable intra-operatively to the pump 24 bytubing 42, and the pump 24 is attachable intra-operatively to eachpenile implant 26 by separate tubing 44.

The components (the reservoir 22, the pump 24, the implants 26, thesleeves 40, and the tubing 42, 44) of the penile prosthetic 20 aregenerally provided unassembled in a kit of parts. The components areassembled immediately prior to surgery, or intra-operatively, asdetermined by the surgeon. For example, each sleeve 40 is slid into arespective one of the expanded corpora cavernosa. Each of the tubinglengths 42, 44 have a portion that is attached to the reservoir 22 and aportion that is attached to the implants 26, respectively, and a portionthat is secured to the pump 24. The bladder 28 is pushed into the sleeve40 that has been inserted in the corpora cavernosum. In someembodiments, the bladder 28 includes a friction reducing coating, or alubricant, to assist in sliding the bladder 28 into the inserted sleeve40. The tubing lengths are connected intra-operatively with some form oftubing connector useful with surgical implants. The components of thepenile prosthetic 20 are illustrated in an assembled configuration inFIG. 1.

The reservoir 22 is sized for implantation within the human body, forexample within the abdomen. The reservoir 22 is sized to retain a volumeof liquid useful in inflating the inflatable bladders 28, for examplewith a volume in a range from 50-350 cc. One useful size of reservoir 22contains about 200 mL of liquid. The liquid is aqueous based. Duringsome procedures the liquid is water, and during other procedures theliquid is saline, depending upon the preference of the surgeon. Suitablematerials for fabricating the reservoir 22 include silicone, polymerssuch as urethanes, a blend of polymers with urethane, copolymers ofurethane, or the like. In one exemplary fabrication process, one of thesuitable materials identified above is molded into a container shapeappropriate for implantation in the space of Retzius or in the abdomen.

The pump 24 includes a pump bulb 50 connected to a pump housing 52. Thepump bulb 50 is pliant and configured to be repeatedly squeezed by theuser of the prosthetic 20 to move liquid into and out of the implants26. The pump housing 52 contains the valving that operates to allow aone-way flow of liquid from the reservoir 22 to the inflatable bladders28 in response to a squeezing of the pump bulb 50, and a one-way flow ofliquid out of the inflatable bladders 28 back to the reservoir 22 inresponse to a touch of the deflation button 54.

The penile implants 26 are sized to be implanted into the penis. Each ofthe penile implants 26 includes one inflatable bladder 28 that is sealedor attached to the proximal tip 30. The inflatable bladders 28 arefabricated from material configured to be flexible when deflated toprovide the penis with a natural, flaccid state and expand when inflatedwith liquid to provide the penis with an erect state. Suitable materialfor fabricating the inflatable bladders 28 includes silicone, polymerssuch as urethanes, a blend of polymers with urethane, copolymers ofurethane, or the like. Suitable penile implants 26 are available fromColoplast Corp., Minneapolis, Minn.

The inflatable bladder 28 is a thin-walled balloon-like tube made of asoft polymer. The distal tip 32 is sealed closed. The inflatable bladder28 is suitably manufactured in a molding process or other process tofabricate a thin and substantially uniform wall thickness that forms aninternal cavity. The style of penile implant that is implanted with aKeith needle and a Furlow device has a reinforced/strengthened distaltip that allows the implant to be towed into place by a suture that isinserted through a hole in the distal tip of the implant. Such areinforced distal tip potentially has an unnaturally hard configurationthat can feel cold or potentially “unnatural” when implanted in a penis.In contrast, the inflatable bladder 28 may be fabricated to include auniform wall thickness such that the distal tip 32 is uniformly thin,more compliant, and possibly more natural feeling than an implant with areinforced tip.

In one embodiment, the proximal tip 30 has a durometer in a range from40 Shore A to 70 Shore A and the distal tip 32 is softer than theproximal tip 30 and has a durometer in a range from 0 Shore A to 39Shore A. The proximal tip 30 is formed of a hardened material adapted tobrace against the bony crus penis within the pelvis. The soft distal tip32 is implanted in the glans penis and is both flexible and pliant toprovide the user with a natural-feeling penis tip. The penile implant 26does away with the use of the Keith needle, and thus does away with thehole formed in the distal tip. Prior devices that have a hole in thedistal tip to accommodate the suture that pulls the Keith needle areassociated with a harder distal tip that might possibly be less naturalfeeling to the user. The penile implant 26 allows for crafting thedesired and improved shape of the distal tip 32 and is characterized byan absence of a suture tow hole and is noticeably softer than the distaltip of prior devices.

FIG. 2 is a side view of the insertion sleeve 40, FIG. 3 is an end viewof the insertion sleeve 40, and FIG. 4 is a side view of the insertionsleeve 40 placed over the bladder 28.

In one embodiment, the insertion sleeve 40 has a length L that is longerthan the length of the bladder 28. In one embodiment, the insertionsleeve 40 has a length L that is the same as the length of the bladder28. In one embodiment, the insertion sleeve 40 has a length L that isless than the length of the bladder 28. In one exemplary embodiment, theinsertion sleeve 40 has a length that is about 75% the length of thebladder 28, which allows the surgeon to grasp the implant 28 on thebladder potion that is not covered by the sleeve 40.

The insertion sleeve 40 has a thickness T selected to configure theinsertion sleeve 40 to dissolve within 24 hours after implantation,preferably within 4 hours after implantation. In one embodiment, theinsertion sleeve 40 has a thickness T in a range from 0.008 inches to0.020 inches, and preferably about 0.015 inches. The thickness isproportional to the time for dissolution of the sleeve 40, so thethickness of the sleeve depends upon the concentration of the gellingagent in solution and upon the selection of the gelling agent.

In one embodiment, the insertion sleeve 40 is inserted into the dilatedcorpora of the penis and the bladder 28 of the implant 26 issubsequently inserted into the sleeve 40.

In one embodiment, the insertion sleeve 40 is placed over the bladder 28of the implant 26 and this combination is subsequently inserted into thedilated corpora of the penis.

The insertion sleeve 40 is placed over the inflatable bladder 28 toprovide the penile implant 26 with an increased column strength. Theincreased column strength is useful to allow the surgeon to push theassembled penile implant 26 into a dilated corpora cavernosum of thepenis. It is desirable that the penile implant 26 have a sufficientcolumn strength to allow the surgeon to push the implant 26 into thepenis during an implantation procedure. However, it is also desirablethat the increased column strength associated with the penile implant 26can be removed or otherwise reduced to allow the implant 26 to occupy anatural, flaccid penis state. Embodiments provide examples of insertionsleeves that have a sufficient column strength to allow the surgeon toinsert the cylinder into a corpora cavernosum during an implantationprocedure, where the insertion sleeve is configured to dissolve ordisassociate or lose its column strength within about 60-120 minutes,preferably 30-60 minutes after implantation or exposure to an aqueousliquid. This allows for a stiff insertion sleeve during insertion and aflaccid insertion sleeve minutes after implantation.

In one embodiment, the insertion sleeve 40 is fabricated from a materialthat dissolves in the presence of an aqueous liquid such as water orsaline. One such insertion sleeve 40 is dissolvable in water having atemperature in a range from 70-100 degrees Fahrenheit.

In one embodiment, the insertion sleeve 40 is fabricated as a cylinderfrom an aqueous solution of a gelling agent derived from animal protein,a gelatin, collagen, plant polysaccharides or their derivatives likecarrageenan, or modified forms of starch and cellulose. Suitableinsertion sleeves 40 are fabricated from starch, polysaccharides,derivatives of polysaccharides, sugar, simple sugars, fructose orderivatives of fructose, modified forms of starch, or modified forms ofstarch and cellulose. Insertion sleeves fabricated from such materialswill dissolve when exposed to water. The gelling agent can includeadditives like plasticizers, glycerin, sorbitol, coloring agents,preservatives, or lubricants. The gelling agent is coated onto a mandrelin the shape of the bladder 28, for example, and allowed to harden intothe sleeve 40. The hardened sleeve 40 is removed from the mandrel andhas an increased column strength over the bladder 28 alone, and anincreased column strength over a penile implant without the insertionsleeve 40. The insertion sleeve 40 is adapted to go into solution and isabsorbed into the body and is imperceptible to the user.

FIG. 5 is a schematic view of the insertion sleeve 40 providing theimplant 26 with increased column strength. The implant 26 is insertedbetween opposing rams of a testing device. A force F is applied to oneof the movable rams to apply an axial force to the implant 26. Absentthe insertion sleeve 40, a penile implant will support a column force Fof less than 1 pound before buckling under load. With the insertionsleeve 40, the portion of the bladder 28 that is covered by the sleeve40 is provided with an effective column strength, which is a columnstrength above 1 pound force, with a working example of the implant 26having a range of column strength from 1-20 pounds force. One suitableeffective column strength for the implant 26 provided with the insertionsleeve 40 is an effective column strength in a range from 1.25-10 poundsforce.

In one embodiment, the insertion sleeve 40 has a durometer in a rangefrom 40 Shore A to 70 Shore A prior to exposure to an aqueous liquid.

FIG. 6, FIG. 7, and FIG. 8 are schematic views of an implantationprocedure for the penile implant 26.

The groin area 100 of the patient is shaved, cleaned and suitablyprepped with a surgical solution prior to draping with a sterile drapeas directed by the healthcare provider's procedures. A retraction device102, such as those available from Lone Star Medical Products ofStafford, Tex., is placed around the penis P if so desired by thesurgeon to establish the surgical field. A catheter 103 is inserted intothe urethra U from the distal end 104 of the penis P. The penis P isreclined against the torso and incised to expose the corpora cavernosa(C1 and C2).

Suitable examples of incisions include either an infrapubic incision ora transverse scrotal incision. The infrapubic incision is initiatedbetween the umbilicus and the penis (i.e., above the penis), whereas thetransverse scrotal incision is made across an upper portion of thepatient's scrotum Sc.

As an example of the transverse scrotal approach, the surgeon forms a2-3 cm transverse incision through the subcutaneous tissue of the medianraphe of the upper scrotum Sc and dissects down through the Darto'sfascia and Buck's fascia to expose the tunicae albuginea of the penis P.Thereafter, each corpora cavernosum C1 and C2 is exposed in acorporotomy where a small (approximately 1.5 cm) incision is formed toallow the surgeon to access and subsequently dilate the corporacavernosa C1 and C2.

The surgeon typically will insert a blunt-ended scissors or otherelongated sleeve to separate a portion of the spongiosum material toopen a pathway for dilation and measurement of the corpora cavernosumC1, C2. After suitable dilation, the surgeon measures the length of thecorpora cavernosa to determine the suitable size for the penile implant26. In one approach, the surgeon ensures that the appropriately sizedpenile implant 26 has been selected by measuring the proximal and distallength of each corpora cavernosum C1 and C2. For example, a ruler isinserted into one of the corpora cavernosa C1 or C2 forward in thedistal penis toward the glans penis, the distal measurement is recordedby reading the ruler, and the ruler is inserted into the same corporacavernosa C1 or C2 rearward in the proximal penis toward the crus of thepenis to record the proximal length of the corpora by reading the ruler.The distal and proximal measurements would typically be made inreference to a “stay stitch” temporarily placed in the incision. The sumof the distal and the proximal measurements represent the length of thatcorpora cavernosum, and this information is employed to select a size ofthe penile implant 26. This procedure is repeated for the other of thecorpora cavernosa C1 or C2 to ensure the appropriately sized penileimplant 26 has been selected for the companion corpora.

FIG. 6 is a schematic view after the surgeon has pushed the of theinsertion sleeve 40 into the corpora cavernosum C1, for example with afinger or with a blunt cavernatome tool.

FIG. 7 is a schematic view of the implant 26 partially inserted into theinsertion sleeve 40. Some implants include a hydrophilic coating. Whenwetted with water, the hydrophilic coating makes the bladder 28 slipperyand easily insertable into the insertion sleeve 40.

FIG. 8 is a schematic view of the implant 26 fully inserted and seatedinto the insertion sleeve 40.

A similar implantation procedure is performed as the second penileimplant 26 is inserted into the second corpora cavernosum C2.

The surgeon connects the tubing between the reservoir 22, the pump 24,and the implants 26 (see FIG. 1) and confirms that the penile prosthetic20 is operating appropriately. The incision is closed. No Keith needlehas been employed and no tow suture was used to place the implant 26 inthe penis.

In one embodiment, the implant includes a hydrophilic coating, forexample on at least the bladder 28 portion. Wetting the hydrophiliccoating on the exterior surface of the penile implant provides thepenile implant with a lubricated surface, which allows the surgeon toslide the lubricated surface of the penile implant into the insertionsleeve.

In another approach, the sleeve 40 is placed over the bladder 28 priorto inserting the combined sleeve 40 and the bladder 28 into the dilatedcorpora cavernosum C1. The insertion sleeve 40 provides the penileimplant 26 with a column strength that is sufficient to allow thesurgeon to push the penile implant 26 in a distal direction to thedistal end 104 of the penis. The surgeon would typically grasp thebladder 28 immediately proximal of the sleeve 40 prior to inserting thesleeve 40 and the bladder 28 into the penis. In the presence ofirrigation liquid or body fluid the insertion sleeve 40 softens,dissolves, disassociates, or otherwise is absorbable into the body afterimplantation. The surgeon subsequently places the proximal end 30 of theimplant 26 into the crus penis.

Embodiments of the penile prosthetic include an insertion sleeve that isdissolvable in water or an aqueous liquid, which advantageously allowsthe insertion sleeve to soften or dissolve after having provided theimplant with an effective column strength that allows the surgeon toimplant the device without a Keith needle or tow suture.

Embodiments of the penile prosthetic include an insertion sleeve that isdissolvable in an aqueous liquid having a temperature in a range from70-100 degrees Fahrenheit, which advantageously allows the insertionsleeve to dissolve after implantation in the human body.

Embodiments of the penile prosthetic include an insertion sleeve formedfrom a gelatin, a collagen, a carrageenan, a starch, polysaccharides,derivatives of polysaccharides, sugar, simple sugars, fructose,derivatives of fructose, modified forms of starch, or modified forms ofstarch and cellulose. Such an insertion sleeve is rigid and strong whendry to advantageously allow insertion of the implant into the penis, anddissociates or dissolves when exposed to an aqueous liquid.

Embodiments of the penile prosthetic include an insertion sleeve with anincreased effective column strength relative to the bladder, whichadvantageously provides the implant with an implantation column strengthin a range from 1-10 pounds force to allow implantation without a Keithneedle or tow suture.

Embodiments of the penile prosthetic include an insertion sleeve with adurometer in a range from 40 Shore A to 70 Shore A, which advantageouslyprovides the implant with an implantation column strength in a rangefrom 1-10 pounds force to allow implantation without a Keith needle ortow suture.

Although specific embodiments have been illustrated and described, itwill be appreciated by those of ordinary skill in the art that a varietyof alternate and equivalent implementations may be substituted for thespecific embodiments shown and described without departing from thescope of the present invention. This application is intended to coverany adaptations or variations of the kind of medical devices describedabove. Therefore, it is intended that this invention be limited only bythe claims and their equivalents.

What is claimed is:
 1. A penile prosthetic comprising: a penile implantsized for insertion into a dilated corpora cavernosum of a penis, thepenile implant includes a proximal tip that is insertable into a cruspenis and an inflatable bladder connected to the proximal tip, theinflatable bladder has a distal tip that is insertable into a glanspenis; and an insertion sleeve having a sleeve wall extending from anopening formed in a proximal end of the insertion sleeve to a closeddistal end of the insertion sleeve, with the closed distal end of theinsertion sleeve configured to enclose the distal tip of the inflatablebladder when the insertion sleeve is attached over an outside surface ofthe inflatable bladder; wherein the insertion sleeve is soluble in oneof water and saline.
 2. The penile prosthetic of claim 1, wherein theinsertion sleeve is dissolvable in an aqueous liquid having atemperature in a range from 70-100 degrees Fahrenheit.
 3. The penileprosthetic of claim 1, wherein the insertion sleeve is formed from amaterial selected from a group consisting of starch, polysaccharides,derivatives of polysaccharides, sugar, simple sugars, fructose,derivatives of fructose, and a combination of starch and cellulose. 4.The penile prosthetic of claim 1, wherein the insertion sleeve is formedfrom one of a gelatin, a collagen, and a carrageenan.
 5. The penileprosthetic of claim 1, wherein the inflatable bladder has a first columnstrength in a range from ¼-¾ pounds force, and the insertion sleeveprovides the penile implant with an effective column strength in a rangefrom 1-10 pounds force.
 6. The penile prosthetic of claim 1, wherein theinsertion sleeve has a durometer in a range from 40 Shore A to 70 ShoreA.
 7. The penile prosthetic of claim 1, wherein the proximal tip has adurometer in a range from 40 Shore A to 70 Shore A and the distal tip issofter than the proximal tip and has a durometer in a range from 0 ShoreA to 39 Shore A.
 8. A method of implanting a penile prosthetic, themethod comprising: forming an incision in skin of a penis; exposing acorpora cavernosum of the penis; inserting an insertion sleeve into thecorpora cavernosum of the penis, where the insertion sleeve isdissolvable in an aqueous liquid; inserting a penile implant into theinsertion sleeve; and closing the incision in the skin of the penis. 9.The method of claim 8, further comprising wetting a hydrophilic coatingon an exterior surface of the penile implant providing the penileimplant with a lubricated surface; and sliding the lubricated surface ofthe penile implant into the insertion sleeve.
 10. The method of claim 8,further comprising irrigating the insertion sleeve and sliding thepenile implant into the insertion sleeve.
 11. The penile prosthetic ofclaim 1, wherein the insertion sleeve is adapted insert the penileimplant into the dilated corpora cavernosum of the penis without asuture.
 12. The penile prosthetic of claim 1, wherein the insertionsleeve is adapted insert the penile implant into the dilated corporacavernosum of the penis without a suture and without an externalinsertion tool.